Genotype-directed Neoadjuvant Chemoradiation for Rectal Carcinoma
NCT ID: NCT00682786
Last Updated: 2017-10-06
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
135 participants
INTERVENTIONAL
2002-10-31
2010-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4)
Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable.
5FU
Radiation
Surgery of resectable lesions
Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4)
Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Irinotecan 50 mg/m2 IV weekly for 5 doses.
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable.
5FU
Radiation
Surgery of resectable lesions
Irinotecan
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
5FU
Radiation
Surgery of resectable lesions
Irinotecan
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Lesion evaluated by surgeon and found to be resectable
* Stage T3 or T4 disease on radiography or ultrasound
* Karnofsky Performance Status at \>60
* Laboratory criteria:
* Absolute neutrophil count \>= 1.5 K
* Platelets \>= 100 K
* Total Bilirubin \<= 2.0;
* SGOT and Alkaline Phosphatase \<= 2 x upper limit of normal
* Creatinine \< 2.0
* Informed consent signed
* Patients with distant metastatic disease will be eligible if they satisfy all other conditions.
Exclusion Criteria
* Patients with a past history of pelvic radiotherapy.
* Patients with prior malignancy in the past 5 years except: skin cancer or in-situ cervical cancer. However, patients with synchronous adenocarcinomas are eligible provided either (a) the synchronous adenocarcinoma was in a removed pedunculated polyp and did not invade the stalk or (b) the synchronous adenocarcinoma was in a removed polyp that lay within the surgical field (extent of resection would not be changed) or (c) the synchronous adenocarcinoma is smaller than the index rectal cancer and lies completely within the radiation field (clinically favorable second lesion and the extend of radiation and surgery would not be changed).
* Patients with known allergy to 5-fluorouracil or irinotecan
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Washington University School of Medicine
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Benjamin Tan, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Washington University School of Medicine
St Louis, Missouri, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
02-0561
Identifier Type: -
Identifier Source: org_study_id